What needs to be in a technical file?

As a manufacturer or importer, you must compile the technical documentation detailed in the EU directive/s concerning risk analysis and product compliance. This documentation should prove compliance with the directive/s and should be stored within the European Union for about 10 years after the last product has been sold. If requested by authorities, this documentation and a copy of the CE Declaration of Conformity must be made available within a short time frame. 

Normally a technical file includes information about design, manufacture, and use of a product. In other words, it contains everything needed to show that the essential requirements of products bearing the CE marking have been met.

What the technical file may include

• A general description of the product
• Information about the product design (for instance circuit diagrams, design drawings, mechanical drawings, component list, manufacturing documentation, etc.)
• Description and explanations necessary to understand the abovementioned drawings.
• Installation description and user manual for the product. The installation description must clarify how the product will be installed and used. The user manual must be written in the language of the country where the product will be sold.
• A list of the standards used either fully or partially, or own standards/methods used to verify compliance with the directive.
• Other grounds used or that may be of use (such as calculations, simulations, etc.)
• Test reports

The manufacturer/importer must keep copies of the technical file for a period of time, usually 10 years, after the last product was placed on the market. This timeframe may vary depending on the directive.